Evaluation of the Dermal Cooling System for Treatment of Common Skin Conditions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-10

Study Completion Date

2023-11-01

Brief Summary

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The purpose of this study is to evaluate whether the Dermal Cooling System can be used to elicit an improvement in the cosmetic appearance or physical symptoms of common skin conditions.

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Detailed Description

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This is a prospective, non-randomized, open-label study to evaluate the effectiveness of the Dermal Cooling system to determine if cosmetic benefits or physical symptoms are achieved in common skin conditions.

Conditions

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Skin Lesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with Dermal Cooling System

Dermal Cooling System will be used in all eligible subjects.

Group Type EXPERIMENTAL

Dermal Cooling System

Intervention Type DEVICE

Controlled localized cooling may be applied to lesions using the Dermal Cooling System.

Interventions

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Dermal Cooling System

Controlled localized cooling may be applied to lesions using the Dermal Cooling System.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male or female subjects \> 18 years of age.
2. Subject has a skin condition amenable to cryosurgical treatment including, for example, psoriasis, atopic dermatitis, acne, rosacea, and melasma.
3. Subject is willing to have skin exposed to cooling with the Dermal Cooling System.
4. Subject is willing to have digital photographs taken of the treatment area and agrees to use of photographs for presentation, educational, or marketing purposes.
5. Subject is willing to cover treated area or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher on the treated area for the duration of the study, including the follow-up period, if requested.
6. Subject has read and signed a written informed consent form.
7. Subject is willing to comply with adjuvant topical regimen, as applicable.
8. Subject agrees not to undergo any other procedure(s) in the treatment area during the study.

Exclusion Criteria

1. Dermatological conditions (e.g. vitiligo, open wounds, infection, pre-cancerous or malignant lesions) in the location of the treatment sites that would, in the professional opinion of the investigator, potentially pose an increased risk to the subject
2. Use of Accutane within the previous 6 months
3. History of melanoma
4. Subject is pregnant or intending to become pregnant during the study period
5. Subject is lactating or has been lactating in the past 6 months
6. Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease.
7. History of abnormal wound healing or abnormal scarring
8. Inability or unwillingness to comply with the study requirements.
9. Current enrollment in a clinical study of any other unapproved investigational drug or device.
10. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes